FDA.reportPublic FDA data

Aptima®

Primary DI
15420045506756
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT, CALIBRATOR, HBV VL, US IVD
Catalog number
PRD-03872
Device description
Aptima® HBV Quant Assay Calibrator.
Published
2018-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKTHepatitis Viral B Dna Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKTHepatitis Viral B Dna DetectionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P170025001
P170025002
P170025007
P170025013
P170025017

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170025001Aptima HBV Quant AssayHologic, Inc.2018-01-23MKT
P170025002Aptima HBV Quant AssayHologic, Inc.2018-01-23MKT
P170025007Aptima HBV Quant AssayHologic, Inc.2018-01-23MKT
P170025013Aptima HBV Quant AssayHologic, Inc.2018-01-23MKT
P170025017Aptima HBV Quant AssayHologic, Inc.2018-01-23MKT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045506756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550675615420045506756

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus core nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-35 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
050579217
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999050808Alinity mABBOTT MOLECULAR INC.MKT2023-08-30
00875197006414cobas® HBVRoche Molecular Systems, Inc.MKT2021-12-10
00884999047754Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
00884999047808Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
00884999047815Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
00884999048645Alinity mABBOTT MOLECULAR INC.MKT2020-09-23
15420045506749Aptima®Hologic, Inc.MKT2018-01-30
15420045506763Aptima®Hologic, Inc.MKT2018-01-30
15420045506770Aptima®Hologic, Inc.MKT2018-01-30
00884999042667RealTimeABBOTT MOLECULAR INC.MKT2016-07-28
00875197004717cobas® HIV1 Quantitative nucleic acid test for use on the cobas® 68 88 SystemsRoche Diagnostics GmbHMKT2016-02-26
00875197004885cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 SystemRoche Diagnostics GmbHMKT2015-12-04
00884999003057RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999003064RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999003071RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999037762RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
00884999038462RealTimeABBOTT MOLECULAR INC.MKT2014-11-20
04015630936557DOCKING STATION SHORTRoche Molecular Systems, Inc.MKT2014-09-19
04038377020556High Pure System Viral Nucleic Acid KitRoche Molecular Systems, Inc.MKT2014-09-10
00875197002003COBAS® TaqMan® HBV Test, For Use With The High Pure SystemRoche Molecular Systems, Inc.MKT2014-09-10
00875197002034COBAS® AmpliPrep / COBAS® TaqMan® Wash ReagentRoche Molecular Systems, Inc.MKT2014-09-10
00875197002706COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0Roche Molecular Systems, Inc.MKT2014-09-09